Oscillating Positive Expiratory Pressure (OPEP) Therapy in Trauma Patients With Multiple Rib Fractures

Poudre Valley Health System

Status: Enrolling

Conditions: Respiratory Complication; Rib Fractures

Treatments: Device: Incentive spirometry; Device: Oscillating Positive Expiratory Pressure Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04100512

OPEP7292019

Details and patient eligibility

About

To determine the efficacy of oscillatory positive expiratory pressure (OPEP) therapy on patients admitted through the trauma service line for rib fractures, as compared to incentive spirometry (IS).

Full description

Patients identified through screening procedures to fit the inclusion criteria will be approached, within 48 hours of floor admission, to participate in the study. Once written informed consent is obtained, participants will be randomized, in a 1:1 ratio, into either the IS or OPEP study group.

Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries.

Respiratory Therapy will record FVC three times daily on all study participants until stable (FVC > 1.5L x 4), then daily for up to 7 days or until discharge.

Participants will be contacted on day 30 from discharge, and administered a short questionnaire. All participants will be followed and monitored per standard of care, under the care and supervision of their treating provider teams.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Greater than or equal to 18 years old
• Greater than or equal to 1 Rib Fracture
• Admitted to trauma services at Medical Center of the Rockies (MCR).

Exclusion criteria

• Less than 18 years old
• Any physical injury that creates inability to functionally use devices
• Adults unable to consent or cooperate due to
• Dementia
• Confusion
• On ventilator support
• Moderate to severe Traumatic brain injury (Glasgow Coma Scale < 12)
• Cervical spinal cord injury
• Women who are pregnant

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Incentive spirometry

Active Comparator group

Description:

Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries. Patient diaries will be collected upon discharge for analysis.

Treatment:

Device: Incentive spirometry

Oscillating Positive Expiratory Pressure Device

Experimental group

Description:

Each patient will be instructed on how to use the respiratory therapy device, either IS or OPEP, by research personnel and respiratory therapists. Participants will be instructed to record their compliance with the RT protocol in their respective patient diaries. Patient diaries will be collected upon discharge for analysis.

Treatment:

Device: Oscillating Positive Expiratory Pressure Device